FDA.reportPublic FDA data

SureMAX

Primary DI
00817662020471
Brand
SureMAX
Company
ADDITIVE IMPLANTS, LLC
Model
1
Device description
SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 12mm
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182477000Cervical SpacerAdditive Implants, LLC2019-01-28ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817662020471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817662020471008176620204718176620204710817662020471

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle14degree
Depth12Millimeter
Height15Millimeter
Width18Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6027958850quality@additiveimplant.com

Regulatory Flags#

DUNS number
057002266
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817662027180SureMAX-SA11022-40012023-08-13
00817662027197SureMAX-SA11022-40022023-08-13
00817662027203SureMAX-SA19100-0001-072023-08-13
00817662027210SureMAX-SA11022-40032023-08-13
00817662026237SureMAX-SA11022-30012021-12-12
00817662026244SureMAX-SA11022-31012021-12-12
00817662026251SureMAX-SA11022-32012021-12-12
00817662026268SureMAX-SA11322-RFS142021-12-12
00817662026275SureMAX-SA11322-RFS162021-12-12
00817662026282SureMAX-SA11322-RFS182021-12-12
00817662026299SureMAX-SA11322-RFS202021-12-12
00817662026305SureMAX-SA11322-RVS142021-12-12
00817662026312SureMAX-SA11322-RVS162021-12-12
00817662026329SureMAX-SA11322-RVS182021-12-12
00817662026336SureMAX-SA11322-RVS202021-12-12
00817662024752SureMAX-SA11022-071214052021-09-30
00817662024769SureMAX-SA11022-071214062021-09-30
00817662024776SureMAX-SA11022-071214072021-09-30
00817662024783SureMAX-SA11022-071214082021-09-30
00817662024790SureMAX-SA11022-071214092021-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
07613327353945Aero-CStryker CorporationODP2018-06-28
07613327353952Aero-CStryker CorporationODP2018-06-28
07613327353976Aero-CStryker CorporationODP2018-06-28
07613327347036Tritanium CStryker CorporationODP2017-09-18
07613327347050Tritanium CStryker CorporationODP2017-09-18
07613327347067Tritanium CStryker CorporationODP2017-09-18
07613327347098Tritanium CStryker CorporationODP2017-09-18
07613327347159Tritanium CStryker CorporationODP2017-09-18
07613327347197Tritanium CStryker CorporationODP2017-09-18
07613327347296Tritanium CStryker CorporationODP2017-09-18
07613327347333Tritanium CStryker CorporationODP2017-09-18
07613327347357Tritanium CStryker CorporationODP2017-09-18
07613327347364Tritanium CStryker CorporationODP2017-09-18
07613327349535Tritanium CStryker CorporationODP2017-09-18
07613327360035Tritanium CStryker CorporationODP2017-09-18
07613327360103Tritanium CStryker CorporationODP2017-09-18
07613327360257Tritanium CStryker CorporationODP2017-09-18
07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18
07613252602774AVS Anchor-LStryker CorporationODP2016-09-24